ES2991311T3 - Device for controlling flow in a body organ - Google Patents

Abstract

Remote control device configured to communicate with a signal transmission device. The signal transmission device comprises a first coil wound with a first wire of a first thickness and tuned with a capacitor to a first frequency. The remote control device comprises a second coil wound with a second wire of a second thickness, wherein the second thickness is greater than the first thickness, and wherein the second coil is tuned to the first frequency. The remote control device further comprises a keypad configured to receive input from a user, and wherein the remote control device is configured to initiate transmission of a command signal to the signal transmission device. The signal transmission device is communicatively coupled to a controller configured to receive the command signal transmitted from the remote control device and to transmit a feedback signal to the remote control device. (Automatic translation with Google Translate, no legal value)

Description

DESCRIPTION

Device for controlling flow in a body organ

Field of invention

The present invention relates to controlling the flow of fluids and/or other bodily matter in bodily organs and, in particular, to an apparatus for controlling the flow of urine in the urethra.

Background of the invention

There are diseases that prevent a patient from maintaining normal control of the flow of fluids and/or other bodily matter into a lumen of a body organ. (The term "patient" generally includes humans, but can also include animals.) For example, a patient suffering from urinary incontinence, which is a common condition that is very embarrassing for the patient, usually occurs when the patient has lost complete control of the flow of urine into the urethra due to a malfunctioning urethral sphincter. Anal incontinence is usually caused by a malfunctioning anal sphincter, which causes uncontrolled drainage of fecal matter through the anus. Impotence is usually due to the inability to sufficiently reduce blood flow from the penis to allow for an erection. Reflux disease is usually due to a malfunctioning cardia, which causes stomach acids to be regurgitated into the esophagus when the stomach wall moves during digestion.

A previous solution to the problem of sphincter malfunction has been to implant an artificial sphincter to replace the malfunctioning sphincter. A variety of artificial sphincters have been used in the past. These artificial sphincters have included cuffs, restraints, or inflatable bands that are applied externally around the body organ that is connected to the malfunctioning sphincter.

For example, U.S. Patent No. 3,750,194 discloses a hydraulic cuff applied around the urethra of a patient suffering from urinary incontinence. Hydraulic fluid flowing into the hydraulic cuff causes it to squeeze the urethra and restrict the flow of fluid through it.

U.S. Patent No. 6,074,341 discloses a mechanical device in the form of a loop member that is applied around a body organ to replace the organ's missing or damaged sphincter. The loop member includes a wire that is used to constrict the organ in question to close the lumen thereof.

A disadvantage common to all of the above artificial sphincters is that over time, a hard fibrosis can form around the artificial sphincter, which can cause it to malfunction. Thus, the fibrosis formed can sooner or later turn into a hard fibrotic layer, which can impair the functioning of the artificial sphincter.

Another more serious drawback is that the element that constricts, holds or restricts a body organ may injure the tissue wall of the organ. Thus, one consequence of the element's constricting action on the organ is that the element might erode into the organ over time and, in the worst case, penetrate the constricted part of the organ's wall. Furthermore, blood circulation in the constricted tissue wall part of the organ is eventually impeded by the pressure exerted by the element, so that poor blood circulation, or worse, no blood circulation, causes deterioration of the constricted tissue.

One solution to prevent tissue deterioration due to poor blood circulation might be to apply two or more separately operating constricting elements along respective portions of the organ tissue wall and operate the elements sequentially, thereby giving each portion of the tissue wall time to recover, i.e., to reestablish normal blood circulation while one of the other portions of the tissue wall is constricted. However, an apparatus designed according to this solution would have several disadvantages. First, the apparatus would require a large amount of space, making its implantation impractical. Second, operating the apparatus to move the constricting elements between the constricting and non-constricting positions day and night would require a large power supply. This large power supply would require the implantation of a very large, high-capacity battery and/or a sophisticated system for continuous wireless transmission of power from outside the patient's body for frequent charging of an implanted rechargeable battery. Therefore, due to its large size and high energy consumption, the device would be impractical or even unrealistic. Thirdly, a sophisticated control system would be necessary to control the moving elements. Finally, a device as complicated as the one described above would considerably increase the costs of treating a malfunctioning sphincter.

Another solution to the problem of sphincter malfunction that has been used previously has been electrical stimulation of the sphincter, to restore its normal function, i.e. the contraction and closure of its associated lumen. This solution would work when the normal function of the sphincter is somewhat reduced and has not ceased completely. European patent application 1004330 A1 discloses an example of such a solution, where electrical pulses are delivered to the lower esophageal sphincter of a patient suffering from reflux disease to minimize reflux. However, the esophageal sphincter has to be continuously stimulated with electrical pulses to keep it closed, except when the patient is eating, which may lead to a decrease in the stimulation effect over time. An even more serious drawback of this solution is that continuous stimulation over time could lead to tissue deterioration due to poor blood circulation. European patent application 1263355 B1 relates to an apparatus for the treatment of urinary incontinence comprising a radio-controlled remote implanted hydraulic reservoir for feeding fluid into an inflatable contractible cavity in a urethral restriction unit to temporarily open the passage of urine.

The use of electrical stimulation to restore sphincter function to a malfunctioning sphincter is only possible if the sphincter responds sufficiently to stimulation, i.e. closes the lumen in question. In cases where sphincter function of a sphincter has ceased completely, or the sphincter has been removed from the patient's body, electrical stimulation cannot be used.

Electrical stimulation of body organs other than the sphincters can only insignificantly affect the flow in the organ in question. For example, when the organ is the small intestine of a patient with anal incontinence, electrical stimulation of the small intestine affects fecal flow, but could not completely close the fecal duct, at least not using the necessary low stimulation intensities that are harmless to the human body.

BRIEF SUMMARY OF THE INVENTION

The invention is set forth in the attached independent claim.

In the examples not covered by the claims, the present invention may be combined with a stimulation device, which results in a two-stage influence on the flow of fluids and/or other bodily materials in the lumen of a bodily organ. Thus, the constriction device may gently constrict the tissue wall by applying a relatively weak force against the wall portion, and the stimulation device may stimulate the constricted wall portion to achieve the desired final influence on the flow in the lumen. The expression "gently constricting a portion of the tissue wall" should be understood as constricting the wall portion without substantially impeding blood circulation in the tissue wall.

Flow restriction

The constriction and stimulation devices may be controlled to constrict and stimulate, respectively, to an extent dependent on the flow restriction desired to be achieved in a specific application of the apparatus of the invention. In accordance with one flow restriction option according to the invention, a control device controls the constriction device to constrict the wall portion such that flow in the lumen is stopped. More precisely, the control device may control the constriction device in a first mode to constrict the constricted wall portion to stop flow in the lumen and in a second mode to cease constriction of the wall portion to restore flow in the lumen.

Sensor-controlled stimulation and/or restriction device

As mentioned above, the apparatus may include at least one implantable sensor, wherein the control device controls the constriction device and/or the stimulation device in response to signals from the sensor. Typically, the sensor directly or indirectly senses at least one physical parameter of the patient, or at least one functional parameter of the apparatus, or at least one functional parameter of a medical implant in the patient.

Many types of sensors can be used to detect physical parameters. For example, motion sensors to detect organ movement, i.e. natural contractions such as stomach or intestinal contractions, pressure sensors to sense pressure in the organ, strain sensors to sense tension in the organ, flow sensors to sense fluid flow in the lumen of the organ, spectrophotometric sensors, pH sensors to sense the acidity or alkalinity of the fluid in the lumen of the organ, oxygen sensors to sense the oxygen content of the fluid in the lumen of the organ, or sensors to sense the distribution of stimulation in the stimulated organ. All imaginable sensors can be used to detect any other type of useful physical parameter.

Many different types of sensors that detect functional parameters of the device can also be used to control the constriction device and/or the stimulation device. For example, sensors to detect the electrical parameters of the implanted electrical components of the device, or sensors to detect the performance of the implanted motors of the device.

The sensor may comprise a pressure sensor for detecting as a physical parameter a pressure in the patient's body that is related to the pressure in the lumen of the patient's body organ, wherein the control device controls the constriction device and/or the stimulation device to change the constriction of the wall portion of the patient in response to the pressure sensor detecting a predetermined value of measured pressure.

Alternatively, or in combination with the pressure sensor, a position sensor may be provided to detect as a physical parameter the orientation of the patient relative to the horizontal. The position sensor may be a biocompatible version of what is shown in U.S. Patents 4,942,668 and 5,900,909. For example, the control device may control the constriction device and/or the stimulation device to change the constriction of the wall portion of the patient in response to the position sensor sensing that the patient has assumed a substantially horizontal orientation, i.e., that the patient is lying down.

The sensors described above may be used in any of the embodiments of the invention, where applicable.

The control device may control the constriction device and/or the stimulation device to change the constriction of the patient wall portion in response to the time of day. To do so, the control device may include a clock mechanism for controlling the constriction device and/or the stimulation device to change the constriction of the patient wall portion to increase or decrease the influence on flow in the lumen during different time periods of the day. In the event that a sensor of any of the types described above is provided for sensing a physical or functional parameter, the clock mechanism is used to control the constriction device and/or the stimulation device as long as the parameter sensed by the sensor does not override the clock mechanism, or the sensor is used to control the constriction device and/or the stimulation device as long as the clock mechanism does not override the sensor. Suitably, the control device produces an indication, such as an audible signal or displayed information, in response to the sensor signals.

The control device may comprise an implantable internal control unit that directly controls the constriction device and/or the stimulation device in response to the sensor signals. The control device may further comprise a wireless remote control adapted to set the control parameters of the internal control unit from outside the patient without mechanically penetrating the patient. At least one of the control parameters, which can be adjusted by the wireless remote control, is the physical or functional parameter. Suitably, the internal control unit includes the aforementioned clock mechanism, wherein the wireless remote control is also adapted to adjust the clock mechanism.

Alternatively, the control device may comprise an external control unit outside the patient's body for controlling the constriction device and/or the stimulation device in response to the sensor signals.

Adjustable constriction device

In various alternative embodiments of the invention, the constriction device is adjustable. In these embodiments, there is an operating device for operating the adjustable constriction device to change the constriction of the tissue wall portion of the patient, and in examples useful for understanding the invention but not covered by the claims, the constriction and stimulation devices form a constriction/stimulation unit. The constriction and stimulation devices of the constriction/stimulation unit may in such examples be integrated into a single piece suitable for implantation. The constriction device of the unit comprises contact surfaces sized to contact a length of a tissue wall portion of an organ of the patient, and the stimulation device of the unit comprises a plurality of stimulation elements provided and distributed along the contact surfaces. When the control device controls the stimulation device to stimulate the wall portion, the stimulation elements stimulate different areas of the wall portion along the length of the wall portion. The stimulation elements preferably comprise electrical elements, as described above, to stimulate the wall portion with electrical impulses. However, in most applications of the present invention, it may be convenient to employ other types of stimulation, such as thermal stimulation.

The operating device operates the adjustable constriction device of the constriction/stimulation unit in a manner that depends on the design of the constriction device, as will be explained in the following exemplary embodiments.

1) The constriction device comprises at least two elongated clamping elements having contact surfaces and extending along the wall portion on different sides of the organ, and the operating device operates the clamping elements to clamp the wall portion between the clamping elements to constrain the wall portion of the organ.

2) The constriction device comprises an elongated clamping element having the contact surfaces and extending along the wall portion on one side of the organ, and the operating device operates the clamping element to clamp the wall portion between the clamping element and the bone or tissue of the patient to constrict the wall portion.

3) The constriction device comprises at least two engaging elements having contact surfaces and positioned on different sides of the organ, and the operating device rotates the engaging elements such that the engaging elements engage and constrict the portion of the organ wall.

4) The constriction device comprises at least two articulated clamping elements having contact surfaces and placed on different sides of the organ, and the operating device moves the clamping elements towards each other to clamp the wall portion of the organ between the clamping elements, to constrict the wall portion.

5) The constriction device comprises at least two spaced apart clamping elements having contact surfaces, at least one of the clamping elements being pivotable such that it can rotate in a plane in which the loop of the constriction member extends, and the operating device rotates the pivoting clamping element to change the size of the constriction opening.

6) The constriction device comprises at least one elongated constriction member having the contact surfaces, and forming means for forming the constriction member into at least one substantially closed loop around the organ, wherein the loop defines a constriction opening. The operating device operates the constriction member in the loop to change the size of the constriction opening.

6a) The elongated constricting member comprises a belt having the contact surfaces, and the operating device operates the belt to change the longitudinal extension of the belt in the loop to change the size of the constriction opening. The forming means may form the constricting member or the belt into a loop having at least one predetermined size.

6b) The elongated constriction member is operable to change the size of the constriction opening such that the outer circumferential confining surface of the constriction device is modified or, alternatively, not modified.

6c) The elongated constriction member is elastic and varies its thickness when viewed in a cross section through it, and is operable to rotate about the longitudinal extent of the constriction member.

6d) The elongate constriction member comprises two substantially or partially semicircular frame elements having contact surfaces and hinged to each other such that the semicircular elements can swing relative to each other from a fully open state in which they substantially or partially form a circle to a fully collapsed state in which they substantially form a semicircle.

7) The constriction device is adapted to bend the wall portion of the organ to constrict it.

In the above-mentioned embodiments (1) to (7), it is important that the constriction device is designed to constrict said length of the tissue wall portion of the patient's organ. For this purpose, the constriction device may include two or more of the described constriction elements/members to be applied in a row along said length of the wall portion, wherein said row extends in the direction of flow in the lumen of the organ. Preferably, said constriction elements/members are not inflatable and are mechanically operable or adjustable.

In the aforementioned embodiments (1) to (7), the operating device may mechanically or hydraulically adjust the constriction device of the constriction/stimulation unit. Furthermore, the operating device may comprise an electrically powered operating device for operating the constriction device. For many applications of the present invention, the operating device suitably operates the constriction device such that the lumen passage flow area assumes a size in the constricted state that allows the stimulation device to contract the wall portion such that flow in the lumen stops.

Mechanical operation

Where the operating device mechanically drives the constriction device of the constriction/stimulation unit, it may be non-inflatable. Furthermore, the driving device may comprise a servo system, which may include a gearbox. The term "servo system" encompasses the normal definition of a servomechanism, i.e., an automatic device that controls large amounts of energy by means of very small amounts of energy, but may alternatively or additionally encompass the definition of a mechanism that transfers a weak force acting on a movable element having a long stroke to a strong force acting on another movable element having a short stroke. Preferably, the operating device actuates the constriction device in a non-magnetic and/or non-manual manner. A motor may be operatively connected to the operating device. The operating device may be operable to perform at least one reversible function and the motor may be capable of reversing the function.

Hydraulic operation

Where the operating device hydraulically actuates the constriction device of the constriction/stimulation unit, it includes hydraulic means for adjusting the constriction device.

In one embodiment of the invention, the hydraulic means comprises a reservoir and an expandable/contractible cavity in the constriction device, wherein the operating device distributes hydraulic fluid from the reservoir to expand the cavity, and distributes hydraulic fluid from the cavity to the reservoir to contract the cavity. The cavity may be defined by a balloon of the constriction device abutting the tissue wall portion of the patient's organ such that the patient's wall portion is constricted as the cavity expands and is released as the cavity contracts.

Alternatively, the cavity may be defined by a bellows which displaces a relatively large constricting element of the constriction device, for example, a large balloon abutting the wall portion, so that the patient's wall portion is constricted by contracting the bellows and released by expanding the bellows. Thus, a relatively small addition of hydraulic fluid to the bellows causes a relatively large increase in the constriction of the wall portion. Such a bellows may also be replaced by a suitably designed piston/cylinder mechanism.

When the hydraulic means comprise a cavity in the constriction device, the apparatus of the invention may be designed according to the options listed below.

1) The reservoir comprises first and second wall portions, and the operating device displaces the first and second wall portions relative to each other to change the volume of the reservoir such that fluid is distributed from the reservoir to the cavity, or from the cavity to the reservoir.

1a) The first and second wall portions of the tank are movable relative to each other by means of at least one of a magnetic device, a hydraulic device or an electrical control device.

2) The operating device comprises a pump for pumping fluid between the reservoir and the cavity.

2a) The pump comprises a first actuating member for actuating the pump to pump fluid from the reservoir to the cavity and a second actuating member for actuating the pump to pump fluid from the cavity to the reservoir.

2a1) The first and second activation members are operable by manual manipulation thereof.

2a2) At least one of the activation members operates when subjected to a predetermined external pressure.

2a3) At least one of the first and second actuating members is operable by magnetic means, hydraulic means, or electrical control means.

2b) The apparatus comprises a fluid conduit between the pump and the cavity, wherein the reservoir forms part of the conduit. The conduit and the pump do not have a non-return valve. The reservoir forms a fluid chamber with a variable volume, and the pump distributes fluid from the chamber to the cavity by a reduction in the volume of the chamber and removes fluid from the cavity by an expansion of the volume of the chamber. The apparatus further comprises a motor for driving the pump, wherein the pump comprises a movable wall of the reservoir for changing the volume of the chamber.

In all embodiments 1 to 2b above, where the hydraulic means comprises an expandable cavity in the constriction device, the cavity may be exchanged for a cylinder/piston mechanism for adjusting the constriction device. In this case, the operating device distributes hydraulic fluid between the reservoir and the cylinder/piston mechanism for adjusting the constriction device.

In a special embodiment of the invention, the operating device comprises a reverse servo operatively connected to the hydraulic means. The term "reverse servo" should be understood as a mechanism that transfers a strong force acting on a movable element having a short stroke to a weak force acting on another movable element having a long stroke; i.e. the reverse function of a normal servomechanism. Thus, minor changes in the amount of fluid in a smaller reservoir could be transferred by the reverse servo into major changes in the amount of fluid in a larger reservoir. The reverse servo is particularly suitable for manual operation thereof.

Preferably, the reverse servo comprises an expandable servo reservoir containing servo fluid and a fluid supply reservoir hydraulically connected to the servo reservoir to form a closed conduit system for the servo fluid. The expandable servo reservoir has a first and a second wall portion, which are displaceable relative to each other in response to a change in the volume of the expandable servo reservoir.

According to a first alternative, the first and second wall portions of the servo reservoir are operatively connected to hydraulic means. The reverse servo distributes fluid between the fluid supply reservoir and the expandable servo reservoir to change the volume of the servo reservoir, whereby the hydraulic means is operated to adjust the constriction device.

According to a second alternative, an implantable main reservoir containing a predetermined amount of hydraulic fluid is provided, wherein the reverse servo is operable to distribute hydraulic fluid between the main reservoir and the hydraulic means for adjusting the constriction device. More specifically, the main reservoir is provided with first and second wall portions operatively connected to the first and second wall portions of the expandable servo reservoir such that the volume of the main reservoir is changed when the volume of the expandable servo reservoir is changed. Thus, when the reverse servo distributes servo fluid between the fluid supply reservoir and the expandable servo reservoir to change the volume of the main reservoir, hydraulic fluid is distributed from the main reservoir to the hydraulic means, or from the hydraulic means to the main reservoir. Advantageously, the servo reservoir and the main reservoir are sized such that when the volume of the servo reservoir is changed by a relatively small amount of servo fluid, the volume of the main reservoir is changed by a relatively large amount of hydraulic fluid.

In both of the alternatives described above, the fluid supply reservoir may have first and second wall portions, which are movable relative to each other to change the volume of the fluid supply reservoir to distribute the servo fluid between the fluid supply reservoir and the expandable servo reservoir. The first and second wall portions of the fluid supply reservoir may be movable relative to each other by manual manipulation, a magnetic device, a hydraulic device, or an electrical control device to change the volume of the fluid supply reservoir to distribute the servo fluid between the fluid supply reservoir and the expandable servo reservoir.

In all of the above-noted embodiments 1 to 2b, where the hydraulic means comprises an expandable cavity in the constriction device, or in embodiments where the hydraulic means comprises a hydraulically operable mechanical construction, the operating device may include the reverse servo described above. In a further embodiment of the invention, the hydraulic means includes a first and a second hydraulically interconnected expandable/contractible reservoir. The first reservoir is operatively connected to the constriction device such that the constriction device changes the constriction of the patient wall portion by expanding or contracting the first reservoir. By changing the volume of the second reservoir, hydraulic fluid is distributed between the two reservoirs such that the first reservoir expands or contracts. This embodiment requires no check valves in the fluid communication conduits between the two reservoirs, which is beneficial to long-term operation of the hydraulic means.

Alternatively, the hydraulic means may include first and second hydraulically interconnected piston/cylinder mechanisms in place of the first and second reservoirs described above. The first piston/cylinder mechanism is operatively connected to the constriction device such that the constriction device changes the constriction of the patient wall portion upon operation of the first piston/cylinder mechanism. Actuating the second piston/cylinder mechanism distributes hydraulic fluid between the two piston/cylinder mechanisms such that the first piston/cylinder mechanism adjusts the constriction device.

When the constriction device does not include an expandable/contractible cavity, the constriction device may comprise at least two elongated gripping elements having the aforementioned contact surfaces and extending along the wall portion on different sides of the organ. The hydraulic means, which may include the reverse servo described above, hydraulically moves the elongated gripping elements toward the wall portion to constrict the wall portion. For example, the constriction device may have hydraulic chambers in which the gripping elements slide back and forth, and the hydraulic means may also include a pump and an implantable reservoir containing hydraulic fluid. The pump distributes hydraulic fluid from the reservoir to the chambers to move the gripping elements against the wall portion, and distributes hydraulic fluid from the chambers to the reservoir to move the gripping elements away from the wall portion.

Control device design

The control device suitably controls the constriction/stimulation unit shown in the examples but not covered by the claims from outside the patient's body. Preferably, the control device can be operated by the patient. For example, the control device may comprise a manually operable switch for turning the constriction/stimulation unit on and off, wherein the switch is adapted for subcutaneous implantation in the patient to be operated manually or magnetically from outside the patient's body. Alternatively, the control device may comprise a hand-held wireless remote control, which is conveniently operable by the patient to turn the constriction/stimulation unit on and off. The wireless remote control may also be designed to be worn on the patient's body like a wristwatch. Such a wristwatch-type remote control may output a control signal that follows the patient's body to implanted signal response means of the apparatus.

When the control device wirelessly controls the constriction/stimulation unit from outside the patient's body, the wireless control function is preferably performed non-magnetically, i.e., the control device controls the constriction device of the constriction/stimulation unit non-magnetically. The patient may use the remote control to control the constriction/stimulation unit to adjust the intensity of the stimulation and/or adjust the constriction of the wall portion. The wireless remote control may comprise at least one external signal transmitter or transceiver and at least one internal signal receiver or transceiver implantable in the patient.

The wireless remote control preferably transmits at least one wireless control signal to control the constriction/stimulation unit. The control signal may comprise a frequency, amplitude, phase modulated signal, or a combination thereof, and may be an analog or digital signal, or a combination of an analog and digital signal. The remote control may transmit an electromagnetic carrier wave signal to carry the digital or analog control signal. Also, the carrier signal may comprise digital, analog signals, or a combination of digital and analog signals.

Any of the above control signals may comprise wave signals, for example, a sound wave signal, an ultrasonic wave signal, an electromagnetic wave signal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a microwave signal, a radio wave signal, an X-ray radiation signal, or a gamma radiation signal. Alternatively, the control signal may comprise an electric or magnetic field, or a combined electric and magnetic field.

As mentioned above, the control signal can follow the patient's body to the implanted signal response means of the device.

The control device may include a programmable internal control unit, such as a microprocessor, implantable in the patient to control the constriction/stimulation unit. The control device may further include an external control unit adapted to be outside the patient's body, wherein the internal control unit is programmable by the external control unit. For example, the internal control unit may be programmable to control the constriction/stimulation unit over time, conveniently in accordance with an activity schedule. The apparatus of the invention may comprise an external data communicator and an implantable internal data communicator communicating with the external data communicator, wherein the internal communicator returns data relating to the constriction/stimulation unit to the external data communicator, or the external data communicator provides the data to the internal data communicator.

Energy source

The present invention also features a solution for supplying energy for use in connection with the operation of the constriction/stimulation unit. Thus, in a broad sense, the present invention provides an apparatus for controlling a flow of fluid and/or other bodily matter in a lumen formed by a tissue wall of an organ of a patient, wherein the apparatus comprises an implantable constriction device for gently constricting a portion of the tissue wall to influence flow in the lumen, a stimulation device for intermittently and individually stimulating different areas of the wall portion, while the constriction device constricts the wall portion, to cause contraction of the wall portion to further influence flow in the lumen, wherein the constriction and stimulation devices form an operable constriction/stimulation unit, a power source, and a control device operable from outside the patient's body for controlling the power source to release energy for use in connection with the operation of the constriction/stimulation unit. In a simple form of the invention, the energy source, such as a battery or accumulator, is implantable in the patient's body.

Wireless power transmission

In a more sophisticated form of the invention, which is preferred, the power source is external to the patient's body and the control device controls the external power source to deliver wireless power. In this sophisticated form of the invention, the apparatus comprises a power transmission device that transmits wireless power delivered from outside the patient's body to the inside of the patient's body. Among other things, the wireless power may comprise electromagnetic energy, an electric field, an electromagnetic field, or a magnetic field, or a combination thereof, or electromagnetic waves. The power transmission device may transmit wireless power for direct use in connection with the operation of the constriction/stimulation unit, while the wireless power is being transmitted. For example, when an electric motor or pump operates the constriction device, the wireless power in the form of a magnetic or electromagnetic field may be used to directly power the motor or pump.

Thus, the motor or pump is directly operated during the transmission of the wireless energy. This can be achieved in two different ways: a) by using a transformer device implanted in the patient to transform the wireless energy into energy of a different form, preferably electrical energy, and power the motor or pump with the transformed energy, or b) by using the wirelessly transmitted energy to directly power the motor or pump. Preferably, the wireless energy in the form of an electromagnetic or magnetic field is used to directly influence specific components of the motor or pump in order to create kinetic energy to drive the motor or pump. Such components may include coils integrated into the motor or pump, or materials influenced by magnetic fields, or permanent magnets, where the magnetic or electromagnetic field influences the coils to generate a current to drive the motor or pump, or influences the material or permanent magnets to create kinetic energy to drive the motor or pump.

Preferably, the power transmitting device transmits power by at least one wireless signal, conveniently a wave signal. The wave signal may comprise an electromagnetic wave signal including one of an infrared light signal, a visible light signal, an ultraviolet light signal, a laser signal, a microwave signal, a radio wave signal, an X-ray radiation signal, and a gamma radiation signal. Alternatively, the wave signal may comprise a sound wave or ultrasound signal. The wireless signal may be a digital or analog signal, or a combination of a digital and analog signal.

Transforming wireless energy

In accordance with a particular embodiment of the invention, an implantable energy transformation device is provided for transforming wireless energy of a first form transmitted by the energy transmission device into energy of a second form, which is typically different from the energy of the first form. The constriction/stimulation unit is operable in response to the energy of the second form. For example, the wireless energy of the first form may comprise sound waves, while the energy of the second form may comprise electrical energy. In this case, the energy transformation device may include a piezoelectric element for transforming the sound waves into electrical energy. Optionally, one of the energies of the first form and the energy of the second form may comprise magnetic energy, kinetic energy, sound energy, chemical energy, radiant energy, electromagnetic energy, photographic energy, nuclear energy or thermal energy. Preferably, one of the energies of the first form and the energy of the second form is non-magnetic, non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy transformation device may operate differently or similarly to the energy transmission device. In a special embodiment, the energy transformation device comprises at least one element, such as at least one semiconductor, having a positive region and a negative region, when exposed to energy of the first form transmitted by the energy transmission device, wherein the element is capable of creating an energy field between the positive region and the negative region, and the energy field produces energy of the second form. More specifically, the element may comprise an electrical junction element, which is capable of inducing an electric field between the positive region and the negative region when exposed to energy of the first form transmitted by the energy transmission device, whereby the energy of the second form comprises electrical energy.

The energy transformation device may transform the energy of the first form directly or indirectly into the energy of the second form. An implantable motor or pump may be provided to operate the constriction device of the constriction/stimulation unit, wherein the motor or pump is supplied with the energy of the second form. The constriction device may be operable to perform at least one reversible function and the motor may be capable of reversing the function. For example, the control device may change the polarity of the energy of the second form to reverse the motor.

The energy transformation device may directly power the motor or pump with the transformed energy while the energy of the second form is being transformed from the energy of the first form. Preferably, the energy transformation device directly operates the constriction/stimulation unit with the energy of the second form in a non-magnetic, non-thermal or non-mechanical manner.

Typically, the constriction/stimulation unit comprises electrical components that are energized with electrical energy. Other implantable electrical components of the apparatus may be at least one voltage level protector or at least one constant current protector. Thus, the energy transforming device may transform the energy of the first form into a direct current or a pulsating direct current, or a combination of direct current and pulsating direct current. Alternatively, the energy transforming device may transform the energy of the first form into an alternating current or a combination of direct current and alternating current.

The apparatus of the invention may comprise an internal power source implantable in the patient to supply power for operation of the constriction/stimulation unit. The apparatus may further comprise an implantable switch operable to switch from an "off" mode, in which the internal power source is not in use, to an "on" mode, in which the internal power source supplies power for operation of the constriction/stimulation unit, and/or to power implanted electronic components of the apparatus. The switch may be operated by first-form power transmitted by the power transmitting device or by second-form power supplied by the power transforming device. The switch arrangement described reduces power consumption of the apparatus between operations.

The internal power source may store the second form energy supplied by the energy transformation device. In this case, the internal power source conveniently comprises an accumulator, such as at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery. When the internal power source is a rechargeable battery, it may be charged only at times convenient for the patient, for example when the patient is sleeping. Alternatively, the internal power source may supply power for operation of the constriction/stimulation unit, but is not used to store the second form energy. In this alternative, the internal power source may be a battery and the switch described above may or may not be provided.

Conveniently, the apparatus of the invention comprises an implantable stabiliser for stabilising the energy of the second form. When the energy of the second form is electrical energy, the stabiliser conveniently comprises at least one capacitor.

The energy-transforming device may be designed to be implanted subcutaneously in the patient's abdomen, chest, or head region. Alternatively, it may be designed to be implanted in an orifice of the patient's body and under the mucosa or intramuscularly outside the mucosa of the orifice.

Although the constriction/stimulation unit in the embodiments described above is designed as a single piece, which is more convenient for implantation, it should be noted that, alternatively, the constriction device and the stimulation device could be designed as separate pieces. Either of the constriction and stimulation units described above may alternatively be replaced by two or more separate constriction/stimulation elements, which are controlled independently of each other.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGURE 1A is a schematic view of the hydraulic operating means suitable for operating the constriction device.

FIGURE 1B shows the embodiment of FIGURE 1A with the constriction device constricting a tissue wall of an organ of the patient.

FIGURE 2A is a schematic view of the mechanical operating means suitable for operating the constriction device.

FIGURE 2B shows the embodiment of FIGURE 2A with the constriction device constricting a tissue wall of an organ of the patient.

FIGURE 2C shows a modification of the embodiment of FIGURE 2B.

FIGURE 3 is a schematic sectional view of a mechanically operable non-inflatable constriction device for use in accordance with the invention.

FIGURES 4 and 5 are sectional views taken along lines XVI-XVI and XVII-XVII, respectively, of FIGURE 3.

FIGURE 6 schematically shows an alternative design of the embodiment of FIGURE 3;

FIGURE 7 schematically illustrates an engine arrangement for the design according to FIGURE 6;

FIGURES 8 and 9 are schematic sectional views of two alternative designs of non-inflatable constriction devices of the invention.

FIGURES 10 and 11 illustrate a fully open and reduced constriction opening, respectively, of the embodiment of FIGURE 9;

FIGURE 12 is a schematic view of a further alternative design of a non-inflatable constriction device of the invention.

FIGURES 13 and 14 illustrate a fully open and a reduced constriction opening, respectively, of the embodiment of FIGURE 12;

FIGURE 16 is a schematic view of another alternative design of a non-inflatable constriction device of the invention.

FIGURES 17 and 18 are schematic sectional views, respectively, of another alternative design of a non-inflatable constriction device.

FIGURE 19A is a schematic view of a hydraulically operable inflatable constriction device for use in accordance with the invention.

FIGURE 19B is the same embodiment shown in FIGURE 19A with the constriction device inflated.

FIGURES 20A, 20B, 20C, and 20D are block diagrams illustrating four different hydraulic operating principles of the constriction device shown in FIGURE 19A.

FIGURE 21 is a sectional view of a reservoir with a variable volume controlled by a remote control motor. FIGURES 22A and 22B are perspective views of a reverse servo according to a particular embodiment of the hydraulic operating principle shown in FIGURE 20C.

FIGURE 23 is a schematic view of another hydraulically operable constriction device for use in accordance with the invention.

FIGURE 24A illustrates the constriction device of FIGURE 23 in a constricted state.

FIGURE 24B illustrates the constriction device of FIGURE 23 in a released state.

FIGURE 25 is a schematic block diagram illustrating a general embodiment of the apparatus of the invention, wherein power is transferred to power consuming components of the apparatus implanted in the patient. FIGURES 26 through 37 are schematic block diagrams illustrating twelve embodiments, respectively, based on the general embodiment shown in FIGURE 25, wherein wireless power is transmitted from outside a patient's body to power consuming components of the apparatus implanted in the patient. FIGURE 38 illustrates a power transformation device in the form of an electrical junction element for use in the apparatus of the present invention.

FIGURE 39 is a block diagram illustrating control components of one embodiment of the invention. FIGURE 40 is a schematic view of an exemplary circuit of one embodiment of the invention, wherein wireless energy is transformed into a current.

FIGURE 41A is a schematic view of another mechanically operable non-inflatable constriction device for use in accordance with the invention.

FIGURE 41B shows the constriction device of FIGURE 41A in a constricted state.

FIGURE 41C is an end view of the embodiment of FIGURE 41B.

FIGURE 42 is a schematic block diagram illustrating an arrangement for delivering a precise amount of wireless power used for operation of the constriction/stimulation unit as described above.

FIGURE 43 schematically shows an example of the system, in which the apparatus operates with energy linked to the cable.

FIGURE 44 is a more detailed block diagram of an arrangement for controlling the wireless power transmission used for operation of the constriction/stimulation unit as described above.

FIGURE 45 is a circuit for the arrangement shown in Fig. 7, according to a possible implementation example.

DETAILED DESCRIPTION OF THE INVENTION

With regard to the figures in the drawing, similar reference numbers designate identical or corresponding elements in the different figures.

FIGURES 1A and 1B show hydraulic operating means suitable for operating the constriction device of the embodiments described above. Specifically, FIGURES 1A and 1B show the apparatus of FIGURE 2 provided with such means for hydraulic operation of the constriction device 2. (The stimulation device is not shown.) (The stimulation device is not shown.) Thus, the housing 1 forms two hydraulic chambers 22a and 22b, in which the two holding elements 5, 6 are slidable back and forth relative to the tubular tissue wall portion 8 of an organ of the patient. The hydraulic operating means includes an expandable reservoir 23, such as an elastic balloon, containing hydraulic fluid, conduits 24a and 24b between the reservoir 23 and the hydraulic chambers 22a, 22b, and a two-way pump 25 for pumping the hydraulic fluid into the conduits 24a, 24b. The control device 4 controls the pump 25 to pump hydraulic fluid from the reservoir 23 to the chambers 22a, 22b to move the clamping elements 5, 6 against the wall portion 8, whereby the tubular wall portion 8 is constricted, see FIG. 12B, and to pump hydraulic fluid from the chambers 22a, 22b to the reservoir 23 to move the clamping elements 5, 6 away from the wall portion 8, whereby the tubular wall 8 is released, see FIG. 1A.

Alternatively, the embodiment of FIGURES 1A and 1B may be manually operated by applying suitable manually operable hydraulic means to distribute hydraulic fluid between expandable reservoir 23 and hydraulic chambers 22a, 22b. In this case pump 25 is omitted.

FIGURES 2A and 2B schematically show a mechanically operable embodiment of the invention, comprising an open tubular housing 26 applied over the tubular tissue wall portion 8 of a patient's organ, a constriction device 27 disposed in the housing 26, and a control device 4 for controlling the constriction device 27. A stimulation device (not shown), as described above, is also provided in the housing 26. The constriction device 27 includes a clamping element 28, which is radially movable in the tubular housing 26 toward and away from the tubular wall portion 8 between a retracted position, see FIGURE 2A, and a clamping position, see FIGURE 2B, in which the clamping element 28 smoothly constricts the tubular wall portion 8. The mechanical operating means for mechanically driving the clamping element 28 includes an electric motor 29 coupled to the housing 26 and a telescopic device 30, which is driven by the motor 29 and operatively connected to the clamping element 28. The control device 4 controls the electric motor 29 to expand the telescopic device 30 to move the clamping element 28 against the wall portion 8, whereby the tubular wall portion 8 is constricted, see FIG. 2B, and controls the motor 29 to retract the telescopic device 30 to move the clamping element 28 away from the wall portion 8, whereby the wall portion 8 is released, see FIG. 2A.

Alternatively, the motor 29 may be omitted and the telescopic device 30 may be modified for manual operation, as shown in FIG. 2C. Thus, a spring 30a may be provided which acts to keep the telescopic device 30 expanded to force the gripping element 28 against the wall portion 8. The mechanical operating means may include a subcutaneously implanted lever mechanism 29a that is operatively connected to the telescopic device 30. The patient may push the lever mechanism 29a through the patient's skin 29b to pull the telescopic device 30 against the action of the spring 30a into the retracted position of the telescopic device 30, as indicated by the phantom lines. When the patient releases the lever mechanism 29a, the spring 30a expands the telescopic device 30, whereby the gripping element 28 is forced against the wall portion 8.

FIGURES 3-5 show a mechanically operable constriction device having an elongated constriction member in the form of a circular resilient core 37 with two superimposed end portions 38, 39. The core 37 defines a substantially circular constriction opening and is enclosed in a soft elastic hose 40 except for a releasable and lockable attachment 41 of the core 37, which when released allows application of the core 37 with its hose 40 about a portion of a tubular tissue wall of an organ of the patient. The materials of all of these elements are biocompatible so that they will not be rejected by the patient's body. An operating device 42 for mechanically actuating the longitudinal extension of the core 37 so as to change the size of the restriction opening comprises a drive wheel 43 in frictional engagement with the superimposed end portions 38, 39 of the core 37. The drive wheel 43 is mounted on a support 44 positioned on the hose 40 and provided with two counter-pressure rollers 45, 46 which press the respective end portions 38, 39 of the core 37 against the drive wheel 43 to increase the frictional engagement therebetween. An electric motor 47 of the operating device is connected to the drive wheel 43 via a long flexible drive shaft 48, and is molded together with a remote controlled power supply unit 49 in a silicone rubber body 50. The length of the flexible drive shaft 48 is selected so that the body 50 can be placed in the desired position on the patient's body, conveniently on the abdomen.

The power supply unit 49 may be controlled to power the electric motor 47 to rotate the drive wheel 43 in one direction to reduce the diameter of the core 37 so that the wall portion is constricted, or to rotate the drive wheel 43 in the opposite direction to increase the diameter of the core 37 so that the wall portion is released.

According to a first alternative, a rack gear may be formed at one of the end portions 38, 39 of the core 37 and the drive wheel 43 may be replaced by a drive toothed wheel connected to the other end portion of the core 37 and meshed with the rack gear.

According to a second alternative, the operating device 42 may be designed as a hose clamp driven by a worm screw, i.e. one of the end portions 38, 39 of the core 37 may be provided with threads and the other end portion of the core 37 may be provided with a worm screw, the threads of which interact with the threads of said end portion of the core 37. The threads of said worm screw may also interact with the threads provided on both end portions 38, 39 of the core 37. In this alternative, the electric motor 47 rotates the worm screw in one direction to reduce the diameter of the core 37, so that the wall portion is constricted, or rotates the worm screw in the opposite direction to increase the diameter of the core 37, so that the wall portion is released in one direction to reduce the diameter of the core 37, so that the wall portion is constricted, or rotates the clamping screw in the opposite direction to increase the diameter of the core 37, so that the wall portion is released.

FIGURE 6 shows a constriction device that is identical to the embodiment of FIGS. 3-5, except that the motor 47 is encapsulated in the hose 40 so that it is fixed to the core 37 and has a short drive shaft 51, and that the motor 47 is positioned relative to the core 37 such that the drive shaft 51 extends substantially tangentially to the circular core 37. An angle gear 52 connects the drive shaft 51 to the drive wheel 43.

FIGURE 7 shows a suitable alternative arrangement for the motor 47 in the embodiment of FIGURE 6, comprising a first clamping member 53 secured to one end portion of the core 37 and a second clamping member 54 secured to the other end portion 39 of the core 37. The motor 47 is fixed to the first clamping member 53 and is operatively connected to a worm gear 55 through a gear transmission 56. The worm gear 55 is received at its opposite ends in brackets 57 and 58, which are rigidly fixed to the clamping member 53 and the motor 47, respectively. The second clamping member 54 has a pinion engaged with the worm gear 55. When the motor 47 is driven, the worm gear 55 rotates, and will thereby pull the end portion 39 of the core 37 in one or the opposite longitudinal direction, so that the diameter of the substantially circular core 37 is increased or decreased. The motor 47, the worm gear 55, the gear transmission 56 and the second clamping member 54 constitute a servo system of the type which transfers a weak force acting on one movable element having a long stroke to a strong force acting on another movable element having a short stroke.

FIGURE 8 shows a constriction device including a plurality of arcuate blades 59 arranged as a conventional adjustable opening mechanism of a chamber. A motor 60 drives the blades 59 to change the size of a restriction opening defined by the blades 59.

FIGURES 9-11 show a constriction device including two semicircular elements 61 and 62, which are hinged to each other such that the semicircular elements 61, 62 can oscillate relative to each other between a fully open state in which they substantially form a circle, as illustrated in FIGURE 10, and an angular state, in which the size of the restriction opening defined by the semicircular elements 61, 62 is reduced, as illustrated in FIGURE 11. A motor 63 drives the semicircular elements 61, 62 to rotate them relative to each other.

FIGURES 12-14 show a constriction device including an elastic belt 64 that forms a circle and has a substantially oval cross section. A motor 67 drives the belt 64 to rotate about the longitudinal extent thereof between a fully open state, in which the wider inner side of the belt 64 forms a substantially cylindrical surface, as illustrated in FIGURE 13, and a reduced open state, in which the wider inner side of the belt 64 forms a substantially conical surface, as illustrated in FIGURE 14.

FIGURE 16 shows a constriction device 68 having two rigid hinged clamping elements 69 positioned on opposite sides of a portion of a tubular tissue wall 70 of a patient's organ. An operating device 71 rotates the clamping elements 69 toward each other to clamp the wall portion 70 between the clamping elements 69 to thereby contract the wall portion, and rotates the clamping elements 69 away from each other to release the wall portion from the clamping elements 69.

FIGURES 17 and 18 show an embodiment of the apparatus of the invention comprising a constriction device 300 having three bending members 301, 302, and 303 offset relative to one another in a row along a portion of a tubular tissue wall 304 of an organ of the patient and alternately positioned on opposite sides of the tubular wall 304. (Alternatively, each member 301, 302, and 303 may be shaped like an hourglass.) An operating device (not shown) moves the two outer members 301, 303 laterally against the tubular wall 304 in one direction and the intermediate member 302 against the tubular wall 304 in the opposite direction to bend the tubular wall 304, thereby constraining the tubular wall portion 304, as illustrated in FIG. 18. To release the wall portion 304, the operating device moves the members 301-303 away from the tubular wall portion 304 to the position shown in FIG. 28.

FIGURES 19A and 19B show an elongated hydraulically operable constriction device in the form of a band 72 having an expandable/contractible cavity 73, which is in fluid communication with an adjustable reservoir 74 containing hydraulic fluid. FIGURE 19A illustrates when the band is in a non-constricted state, while FIGURE 19B illustrates when the band is in a constricted state, wherein the cavity 73 is expanded by hydraulic fluid supplied by the reservoir 74.

FIGURES 20A, 20B, 20C, and 20D are block diagrams of four differently operating hydraulic constriction devices. FIGURE 20A shows the band 72 of FIGURE 20A, the cavity 73 of which is in fluid communication with a reservoir 75. FIGURE 20B shows the embodiment of FIGURE 30A, wherein the cavity 73 of the band 72 is in fluid communication with the reservoir 74 through an operating device in the form of a two-way pump 76. FIGURE 20C shows an operating device in the form of a reverse servo system with a first closed system controlling a second system. The reverse servo system comprises an adjustable fluid supply reservoir 77 and an adjustable servo reservoir 78. The servo reservoir 78 controls a larger adjustable reservoir 79 which in connection with the band 72 applied around a tubular tissue wall portion of an organ of the patient varies the volume of the cavity 73 of the band 72, which in turn varies the constriction of the wall portion. FIG. 31D shows an embodiment identical to the embodiment of FIG. 20C, except that the larger reservoir 79 is omitted. Instead, the servo reservoir 78 is in fluid communication with the cavity of the band 72.

In all of the above embodiments according to FIGS. 1A-19B, stimulation devices may be provided to form constriction/stimulation units, wherein the stimulation devices include a multiplicity of electrical elements 7 (indicated in FIGS. 1A-3, 6, 8, 11, 14-20B) positioned in the constriction devices.

21 is a sectional view of a fluid delivery device including a bellows reservoir 80 defining a chamber 81, the size of which is variable by an operating device comprising a remotely controlled electric motor 82. The reservoir 80 and motor 82 are positioned in a housing 83. Movement of a large wall 84 causes the chamber 81 to vary. The wall 84 is fixed to a nut 85, which is screwed onto a rotatable spindle 86. The spindle 86 is rotated by the motor 82. A battery 89 positioned in the housing 83 powers the motor 82. A signal receiver 90 for controlling the motor 82 is also positioned in the housing 83. Alternatively, the battery 89 and signal receiver 90 may be mounted at a separate location. The motor 82 may also be powered by energy transferred by transmitted signals.

Where applicable, the fluid supply device of FIGURE 21 may be used to supply hydraulic fluid for operation of the constriction devices described in this specification. For example, the fluid supply device of FIGURE 21 may be replaced by the reservoir 74 in the embodiment according to FIGURE 19A.

22A and 22B show a reverse servo including a rectangular housing 91 and an intermediate wall 92, which is movable in the housing 91. A relatively large and substantially cylindrical bellows reservoir 93 is disposed in the housing 91 and is attached to the movable intermediate wall 92. Another cylindrical bellows reservoir 94, which is substantially smaller than the reservoir 93, is disposed in the housing 91 on the other side of the intermediate wall 92 and is also attached to the wall 92. The small bellows reservoir 94 has a fluid supply tube 95 and the large bellows reservoir 93 has a fluid supply tube 96.

Referring to FIGURE 22A, when a small amount of hydraulic fluid is led through the supply pipe 95 to the small bellows reservoir 94, the small bellows reservoir 94 expands and pushes the movable intermediate wall 92 toward the large bellows reservoir 93. As a result, the large bellows reservoir 93 is contracted by the intermediate wall 92, whereby a large amount of hydraulic fluid is forced out of the large bellows reservoir 93 through the supply pipe 96, as shown in FIGURE 33B.

For example, the reverse servo of FIGS. 22A and 22B may be used in the embodiment of FIG. 31C, where the small bellows reservoir 94 corresponds to the small servo reservoir 78 and the large bellows reservoir 93 corresponds to the large reservoir 79. Likewise, the reverse servo of FIGS. 22A and 22B may be used in the embodiment of FIGS. 19A and 19B, where the small bellows reservoir 94 is connected to the adjustable reservoir 74, and the large bellows reservoir 93 is connected to the cavity 73 of the band 72.

FIGURE 23 schematically shows a hydraulically operable constriction device 97 of the apparatus of the invention, which is similar to the embodiment shown in FIGURE 19A, except that the hydraulic system is designed differently. Thus, the constriction device 97 includes a relatively small inflatable cavity 98, which is in fluid communication with a reservoir 99 containing hydraulic fluid, and a relatively large cavity 100, which is displaceable by the small cavity 98. The small cavity 98 is adapted to displace the large cavity 100 to constrict the patient's tubular wall portion when the small cavity 98 is inflated and to displace the large cavity 100 to release the wall portion when the small cavity 98 is deflated. Thus, a relatively small addition of hydraulic fluid from the reservoir 99 to the small cavity 98 causes a relatively large increase in the constriction of the wall portion.

The large cavity 100 is defined by a constriction element in the form of a large balloon 101, which may be connected to an injection port (not shown) to calibrate the volume of the large cavity 100. The volume of the balloon 101 is calibrated by adding or withdrawing liquid from the injection port with the aid of a syringe. The small cavity 98 is defined by a small bellows 102 attached to an annular frame 103 of the constriction device 97 and at the opposite end is attached to the balloon 101.

FIGURES 24A and 24B schematically illustrate the operation of the constriction device 97, when the annular frame 103 is applied around the tubular wall portion of the patient's organ. Referring to FIGURE 24A, when the small cavity 98 is deflated, the bellows 102 pulls the balloon 101 into the annular frame 103, such that the constriction device 97 constricts the wall portion. Referring to FIGURE 24B, when the small cavity 98 is inflated, the bellows 102 pulls the balloon 101 out of the annular frame 103, such that the constriction device 97 releases the wall portion.

FIGURE 25 schematically shows a general embodiment of the apparatus of the invention, wherein energy is transferred to energy consuming components of the apparatus implanted in the patient. The apparatus of FIGURE 25 comprises an implanted constriction/stimulation unit 110, which is operable to gently constrict a portion of a tubular tissue wall of an organ of the patient and to stimulate different areas of the constricted portion to cause contraction of the wall portion. The constriction device of the constriction/stimulation unit 110 is capable of performing a reversible function, i.e., constricting and releasing the wall portion, such that the constriction/stimulation unit 110 functions as an artificial sphincter.

A power source 111 is adapted to supply power to the power consuming components of the constriction/stimulation unit 110 via a power line 112. A wireless remote control or a subcutaneously implanted switch may be provided that can be actuated by the patient to activate or deactivate the power supply of the power source. The power source may be an implantable permanent or rechargeable battery, or be included in an external power transmission device, which may be operated directly by the patient or controlled by a remote control operable by the patient to transmit wireless power to the power consuming components of the constriction/stimulation unit. Alternatively, the power source may comprise a combination of an implantable rechargeable battery, an external power transmission device, and an implantable power transformation device to transform the wireless power transmitted by the external power transmission device into electrical energy for charging the implantable rechargeable battery.

FIGURE 28 shows a special embodiment of the general embodiment of FIGURE 25 having some parts implanted in a patient and other parts located outside the patient's body. Thus, in FIGURE 26 all parts positioned to the right of the patient's skin 109 are implanted and all parts positioned to the left of the skin 109 are located outside the patient's body. An implanted power transformation device 111A of the apparatus is adapted to supply power to the power consuming components of the constriction/stimulation unit 110 via the power supply line 112. An external power transmission device 113 of the apparatus includes a wireless remote control that transmits a wireless signal, which is received by a signal receiver incorporated in the implanted power transformation device 111A. The implanted energy transformation device 111A transforms the signal energy into electrical energy, which is supplied through the power line 112 to the constriction/stimulation unit 110.

The apparatus of FIGURE 26 may also include an implanted rechargeable battery for powering the implanted components of the apparatus that consume power. In this case, the implanted power transformation device 111A also charges the battery with electrical energy, as the power transformation device transforms the signal energy into electrical energy.

A reversing device in the form of an electrical switch 114, such as a microprocessor, is implanted in the patient to reverse the constriction device of the constriction/stimulation unit 110. The wireless remote control of the external energy transmitting device 113 transmits a wireless energy-carrying signal and the implanted energy transforming device 111A transforms the wireless energy into a current to actuate the switch 114. When the energy transforming device 111A changes the polarity of the current, the switch 114 reverses the function performed by the constriction device of the constriction/stimulation unit 110.

FIGURE 27 shows an embodiment of the invention that includes the energy transforming device 111A, the constriction/stimulation unit 110, and an implanted operating device in the form of a motor 115 for operating the constriction device of the constriction/stimulation unit 110. The motor 115 is powered by power from the energy transforming device 111A as the external power transmitting device remote control 113 transmits a wireless signal to the energy transforming device receiver 111A.

FIGURE 28 shows an embodiment of the invention that includes energy converting device 111A, constriction/stimulation unit 110, and an implanted assembly 116 that includes a motor/pump unit 117 and a fluid reservoir 118. In this case, the constriction device of the constriction/stimulation unit 110 is hydraulically operated, i.e., hydraulic fluid is pumped by motor/pump unit 117 from reservoir 118 to the constriction/stimulation unit 110 to constrict the wall portion, and hydraulic fluid is pumped by motor/pump unit 117 back from the constriction/stimulation unit 110 to reservoir 118 to release the wall portion. The implanted energy transformation device 111A transforms the wireless energy into a current, to power the motor/pump unit 117.

FIGURE 29 shows an embodiment of the invention comprising the external power transmission device 113 which controls the control unit 122 to reverse the motor 115 when necessary, the constriction/stimulation unit 110, which constriction device is hydraulically actuated, and the implanted energy transformation device 111A, and further comprising an implanted hydraulic fluid reservoir 119, an implanted motor/pump unit 120, an implanted reversing device in the form of a hydraulic valve shifting device 121, and a separate external wireless remote control 111B. The motor of the motor/pump assembly 120 is an electric motor. In response to a control signal from the wireless remote control of the external power transmission device 113, the implanted energy transformation device 111A supplies the motor/pump unit 120 with the energy carried by the control signal, whereby the motor/pump unit 120 distributes hydraulic fluid between the reservoir 119 and the constriction device of the constriction/stimulation unit 110. The remote control 111B controls the switching device 121 to change the direction of the hydraulic fluid flow between a direction in which the fluid is pumped by the motor/pump unit 120 from the reservoir 119 to the constriction device of the constriction/stimulation unit 110 to constrict the wall portion, and another opposite direction in which the fluid is pumped by the motor/pump unit 120 back from the constriction device of the constriction/stimulation unit 110. 110 to reservoir 119 to release the wall portion.

FIGURE 30 shows an embodiment of the invention that includes the energy transforming device 111A and the constriction/stimulation unit 110. A control unit 122, an accumulator 123 and a capacitor 124 are also implanted in the patient. An external wireless remote controller 111B controls the control unit 122. The control unit 122 controls the energy transformation device 111A to store electric energy in the accumulator 123, which supplies power to the constriction/stimulation unit 110. In response to a control signal from the wireless remote controller 111B, the control unit 122 releases the electric energy from the accumulator 123 and transfers the released energy through electric lines, or directly transfers the electric energy from the energy transformation device 111A through the capacitor 124, which stabilizes the electric current, for operation of the constriction/stimulation unit 110.

According to one alternative, the capacitor 124 in the embodiment of FIGURE 30 may be omitted. According to another alternative, the accumulator 123 in this embodiment may be omitted.

31 shows an embodiment of the invention that includes the power transforming device 111A, the constriction/stimulation unit 110. A battery 125 for supplying power for operation of the constriction/stimulation unit 110 and an electrical switch 126 for switching operation of the constriction/stimulation unit 110 are also implanted in the patient. The switch 126 is actuated by power supplied by the power transforming device 111A to transition from an off mode, in which the battery 125 is not in use, to an on mode, in which the battery 125 supplies power for operation of the constriction/stimulation unit 110.

32 shows an embodiment of the invention identical to that of FIG. 43, except that a control unit 122 is also implanted in the patient. A separate external wireless remote control 111B controls the control unit 122. In this case, the switch 126 is operated by power supplied by the power transformation device 111A to switch from an off mode, in which the wireless remote control 111B cannot control the control unit 122 and the battery 125 is not in use, to a standby mode, in which the remote control 111B can control the control unit 122 to release electrical power from the battery 125 for operation of the constriction/stimulation unit 110.

33 shows an embodiment of the invention identical to that of FIG. 44, except that the accumulator 123 is replaced by the battery 125 and the implanted components are interconnected differently. In this case, the accumulator 123 stores energy from the energy transformation device 111A. In response to a control signal from the wireless remote control 111B, the implanted control unit 122 controls the switch 126 to switch from an off mode, in which the accumulator 123 is not in use, to an on mode, in which the accumulator 123 supplies energy for operation of the constriction/stimulation unit 110.

34 shows an embodiment of the invention identical to that of FIG. 45, except that battery 125 is also implanted in the patient, and the implanted components are interconnected differently. In response to a control signal from wireless remote control 111B, implanted control unit 122 controls accumulator 123, which may be a capacitor, to supply power to operate switch 126 to transition from an off mode, in which battery 125 is not in use, to an on mode, in which battery 125 supplies electrical power for operation of constriction/stimulation unit 110.

Alternatively, switch 126 may be actuated by power supplied by accumulator 123 to transition from an off mode, in which wireless remote control 111B cannot control battery 125 to supply electrical power and battery 125 is not in use, to a standby mode, in which wireless remote control 111B can control battery 125 to supply electrical power for operation of constriction/stimulation unit 110.

FIGURE 35 shows an embodiment of the invention identical to that of FIGURE 43, except that a motor 115, a mechanical reversing device in the form of a gearbox 127, and a control unit 122 for controlling the gearbox 127 are also implanted in the patient. A separate external wireless remote control 111B controls the implanted control unit 122 to control the gearbox 127 to reverse the function performed by the constriction device (mechanically operated) of the constriction/stimulation unit 110.

FIGURE 36 shows an embodiment of the invention identical to that of FIGURE 46, except that the implanted components are interconnected differently. Thus, in this case, the battery 125 powers the control unit 122 when the accumulator 123, conveniently a capacitor, activates the switch 126 to change to an on mode. When the switch 126 is in its on mode, the control unit 122 can control the battery 125 to supply, or not supply, power for the operation of the constriction/stimulation unit 110.

FIGURE 37 shows an embodiment of the invention identical to that of FIGURE 39, except that a gearbox 127 connecting the motor 115 to the constriction/stimulation unit 110, and a control unit 122 controlling the energy transformation device 111A to power the motor 115 are also implanted in the patient. There is an external, wireless remote control 111B that controls the control unit 122 to reverse the motor 115 when necessary.

Optionally, the accumulator 123 shown in FIG. 30 may be provided in the embodiment of FIG. 37, wherein the implanted control unit 122 controls the energy transformation device 111A to store the transformed energy in the accumulator 123. In response to a control signal from the wireless remote controller 111B, the control unit 122 controls the accumulator 123 to supply power for operation of the constriction/stimulation unit 110.

Those skilled in the art will realize that the above various embodiments according to FIGS. 25-37 could be combined in many different ways. For example, the power-operated switch 114 could be incorporated into any of the embodiments of FIGS. 27, 30-37, the hydraulic shifting device 121 could be incorporated into the embodiment of FIG. 28, and the gearbox 127 could be incorporated into the embodiment of FIG. 27. The switch 114 may be of a type that includes electronic components, for example a microprocessor, or a FGPA (Field Programmable Gate Array) designed for switching. Alternatively, however, the power-operated switch 114 may be replaced by a subcutaneously implanted push button that is manually switched by the patient between "on" and "off."

Alternatively, a permanent or rechargeable battery may be replaced by the power transformation devices 111A of the embodiments shown in FIGS. 38-49.

FIGURE 38 shows the power transformation device in the form of an electrical junction element 128 for use in any of the above embodiments according to FIGS. 25-37. The element 128 is a planar p-n junction element comprising a p-type semiconductor layer 129 and an n-type semiconductor layer 130 sandwiched together. A light bulb 131 is electrically connected to opposite sides of the element 128 to illustrate how the generated current is obtained. The current output of said p-n junction element 128 is correlated with temperature. See the formula below.

I = I0 (exp(qV/kT)-1)

Where

I is the external current flow,

I0 is the reverse saturation current,

q is the fundamental electronic charge of 1.602 x 10-19 coulombs,

V is the applied voltage,

k is the Boltzmann constant, and

T is the absolute temperature.

Under a large applied negative voltage (reverse bias), the exponential term becomes negligible compared to 1.0, and I is approximately -I0. I0 is strongly dependent on the junction temperature and hence on the intrinsic carrier concentration. I0 is larger for materials with smaller bandgaps than for those with larger bandgaps. The rectifying action of the diode, i.e., its restriction of current flow to a single direction, is in this particular embodiment the key to the operation of the p-n junction element 128.

The alternative way to design a p-n junction element is to deposit a thin layer of semiconductor on a support material that does not absorb the type of energy used in the respective embodiments. For use with wirelessly transmitted energy in terms of light waves, glass could be a suitable material. Various materials can be used in the semiconductor layers, such as cadmium telluride, copper indium diselenide, and silicon. It is also possible to use a multilayer structure with several layers of p- and n-type materials to improve efficiency.

The electrical energy generated by the p-n junction element 128 could be of the same type as that generated by solar cells, where the negative and positive fields create a direct current. Alternatively, the negative and positive semiconductor layers can change polarity following the transmitted waves, thus generating the alternating current.

The p-n junction element 128 is designed to be suitable for implantation. Thus, all external surfaces of the element 128 in contact with the human body are made of a biocompatible material. The p-n junction semiconductors are designed to function optimally at a body temperature of 37°C, since the current output, which must be greater than 1|i A, is significantly dependent on said temperature, as shown above. Since both the skin and the subcutis absorb energy, the relationship between the sensitivity or working area of the element 128 and the intensity or strength of the wireless energy transmission is considered. The p-n junction element 128 is preferably designed to be flat and small. Alternatively, if the element 128 is manufactured in larger sizes, it should be flexible, to adapt to the movements of the patient's body. The volume of the element 128 should be less than 2000 cm3.

FIGURE 39 shows basic parts of a remote control of the apparatus of the invention for controlling the constriction/stimulation unit 110. In this case, the stimulation device of the constriction/stimulation unit stimulates the wall portion with electrical pulses. The remote control is based on the wireless transmission of electromagnetic wave signals, often of high frequencies in the range of 100 kHz - 1 gHz, through the skin 132 of the patient. In FIGURE 39, all parts placed to the left of the skin 132 are located outside the patient's body and all parts placed to the right of the skin 132 are implanted.

An external signal transmitting device 133 may be placed near a signal receiving device 134 implanted near the skin 132. Alternatively, the signal receiving device 134 may be placed, for example, within the patient's abdomen. The signal receiving device 134 comprises a coil of approximately 1 100 mm, preferably 25 mm in diameter, wound with a very fine wire and tuned with a capacitor to a specific high frequency. A small coil is chosen if it is to be implanted under the patient's skin and a large coil if it is to be implanted in the patient's abdomen. The signal transmitting device 133 comprises a coil that is approximately the same size as the coil of the signal receiving device 134, but wound with a thick wire that can handle the larger currents that are necessary. The coil of the signal transmitting device 133 is tuned to the same specific high frequency as the coil of the signal receiving device 134.

The signal transmission device 133 is adapted to send digital information through the power amplifier and signal receiving device 134 to an implanted control unit 135. To prevent high frequency random fields from triggering control commands, digital signal codes are used. A conventional keypad placed on the signal transmission device 133 is used to command the signal transmission device 133 to send digital signals for control of the constriction/stimulation unit. The signal transmission device 133 initiates a command by generating a high frequency signal. After a short time, when the signal has energized the implanted parts of the control system, commands are sent to operate the constriction device of the constriction/stimulation unit 110 in predefined steps. The commands are sent as digital packets in the manner illustrated below.

Commands are sent continuously over a fairly long period of time (e.g., 30 seconds or more). When a new constriction or release step is desired, the count byte is incremented by one to allow the implanted control unit 135 to decode and understand that the signal transmission device 133 is calling for another step. If any part of the digital packet is in error, its contents are simply ignored.

Through a line 136, an implanted energizer unit 137 draws energy from the high frequency electromagnetic wave signals received by the signal receiving device 134. The energizer unit 137 stores the energy in a power source, such as a large capacitor, powers the control unit 135, and powers the constriction/stimulation unit 110 through a line 138.

The control unit 135 comprises a demodulator and a microprocessor. The demodulator demodulates the digital signals sent from the signal transmission device 133. The microprocessor receives the digital packet, decodes it and sends a control signal through a signal line 139 to control the constriction device of the constriction/stimulation unit 110 to constrict or release the wall portion of the patient's organ depending on the command code received.

FIGURE 40 shows a circuit of one embodiment of the invention, wherein wireless energy is transformed into a current. External components of the circuit include a microprocessor 140, a signal generator 141, and a power amplifier 142 connected thereto. Microprocessor 140 is adapted to turn signal generator 141 on and off and to modulate the signals generated by signal generator 141 with digital commands. Power amplifier 142 amplifies the signals and sends them to an external signal transmitting antenna coil 143. Antenna coil 143 is connected in parallel with a capacitor 144 to form a resonant circuit tuned to the frequency generated by signal generator 141.

The implanted circuit components include a signal receiving antenna coil 145 and a capacitor 146 that together form a resonant circuit that is tuned to the same frequency as the transmitting antenna coil 143. The signal receiving antenna coil 145 induces a current from the received high frequency electromagnetic waves and a rectifier diode 147 rectifies the induced current, which charges a storage capacitor 148. The storage capacitor 148 powers a motor 149 to drive the constriction device of the constriction/stimulation unit 110. A coil 150 connected between the antenna coil 145 and the diode 147 prevents the capacitor 148 and the diode 147 from charging the signal receiving antenna circuit 145 at higher frequencies. Thus, the coil 150 allows the capacitor 148 to be charged and digital information to be transmitted by amplitude modulation.

A capacitor 151 and a resistor 152 connected in parallel and a diode 153 form a detector used to detect amplitude modulated digital information. A filter circuit is formed by a resistor 154 connected in series with a resistor 155 connected in series with a capacitor 156 connected in series with the resistor 154 through ground, and a capacitor 157, one terminal of which is connected between the resistors 154,155 and the other terminal is connected between the diode 153 and the circuit formed by the capacitor 151 and the resistor 152. The filter circuit is used to filter out unwanted low and high frequencies. The detected and filtered signals are sent to an implanted microprocessor 158 which decodes the digital information and controls the motor 149 through an H-bridge 159 comprising transistors 160, 161, 162 and 163. The motor 149 can be driven in two opposite directions by the H-bridge 159.

The microprocessor 158 also monitors the amount of energy stored in the storage capacitor 148. Before sending signals to activate the motor 149, the microprocessor 158 checks whether the energy stored in the storage capacitor 148 is sufficient. If the stored energy is not sufficient to perform the requested operation, the microprocessor 158 waits for the received signals to charge the storage capacitor 148 before activating the motor 149.

Alternatively, the energy stored in the storage capacitor 148 may be used solely to power a switch, and the energy to power the motor 149 may be obtained from another relatively high capacity implanted power source, for example a battery. In this case, the switch is adapted to connect the battery to the motor 149 in an on mode when the switch is powered by the storage capacitor 148 and to keep the battery disconnected from the motor 149 in a standby mode when the switch is not powered.

FIGURES 41A, 41B and 41C show another mechanically operable constriction device 213 for use in the apparatus of the invention. Referring to FIGURE 41A, the constriction device 213 includes a first ring-shaped support 214 engaged on a tubular organ 8 of a patient and a second ring-shaped support 215 also engaged on the organ 8 spaced from the support 214. Elastic cords 216 (in this case twelve cords) extend in parallel along the tubular organ 8 and interconnect the two supports 213, 214 without contacting the organ 8. FIGURE 41A illustrates an inactivated state of the constriction device 213 in which the organ 8 is not constrained.

Referring to FIGS. 41B and 41C, when the organ 8 is to be constrained, the ring-shaped supports 213 and 214 are rotated by an operating means (not shown) in opposite directions, whereby the elastic cords 216 constrain the organ 8 in a manner shown in FIGS. 41B and 41C. For the sake of clarity, only five cords 216 are shown in FIG. 41B.

42 schematically illustrates an apparatus arrangement that is capable of sending information from within the patient's body to the exterior thereof to provide information relating to at least one functional parameter of the apparatus, and/or relating to a physical parameter of the patient, in order to deliver a precise amount of energy to an implanted internal energy receiver 302 connected to energy consuming components of an implanted constriction/stimulation unit 301 of the apparatus of the invention. Such energy receiver 302 may include a power source and/or an energy transformation device. Briefly described, wireless energy is transmitted from an external power source 304a located outside the patient and is received by the internal energy receiver 302 located within the patient. The internal power receiver is adapted to directly or indirectly supply the received power to the power consuming components of the constriction/stimulation unit 301 via a switch 326. A power balance is determined between the power received by the internal power receiver 302 and the power used by the constriction/stimulation unit 301, and the wireless power transmission is then controlled based on the determined power balance. The power balance thus provides an accurate indication of the correct amount of power needed, which is sufficient to operate the constriction/stimulation unit 301 properly, but without causing an undue rise in temperature.

In FIGURE 42, the patient's skin is indicated by a vertical line 305. Here, the energy receiver comprises an energy transforming device 302 positioned within the patient, preferably just beneath the patient's skin 305. In general, the implanted energy transforming device 302 may be placed in the abdomen, chest, muscle fascia (e.g., abdominal wall), subcutaneously, or any other suitable location. The implanted energy transforming device 302 is adapted to receive wireless energy E transmitted from the external energy source 304a provided at an external energy transmitting device 304 positioned outside the patient's skin 305 in proximity to the implanted energy transforming device 302.

As is well known in the art, wireless energy E can generally be transferred by means of any suitable Transcutaneous Energy Transfer (TET) device, such as a device including a primary coil disposed in the external power source 304a and an adjacent secondary coil disposed in the implanted power transformer device 302. When an electrical current is introduced through the primary coil, energy in the form of a voltage is induced in the secondary coil which can be used to power the implanted power consuming components of the apparatus, for example, after storing the incoming energy in an implanted power source, such as a rechargeable battery or capacitor. However, the present invention is not generally limited to any particular power transfer technique, TET devices, or power sources, and any type of wireless energy can be used.

The amount of energy received by the implanted energy receiver can be compared to the energy used by the implanted components of the apparatus. The term "energy used" is then understood to also include the energy stored by the implanted components of the apparatus. A control device includes an external control unit 304b that controls the external energy source 304a based on the determined energy balance to regulate the amount of energy transferred. In order to transfer the correct amount of energy, the energy balance and the amount of energy required are determined by a determining device including an implanted internal control unit 315 connected between the switch 326 and the constriction/stimulation unit 301. The internal control unit 315 is therefore arranged to receive various measurements obtained by suitable sensors or the like, not shown, which measure certain characteristics of the constriction/stimulation unit 301, thereby reflecting in some way the amount of energy required for proper operation of the constriction/stimulation unit 301. Furthermore, the current state of the patient is also detected by suitable measuring devices or sensors, in order to provide parameters reflecting the state of the patient. Such characteristics and/or parameters may therefore be related to the current state of the constriction/stimulation unit 301, such as in particular the temperature but also the power consumption, the operating mode, as well as the patient's condition reflected by parameters such as in particular the body temperature, but also the blood pressure, heartbeat and respiration. Other types of physical parameters of the patient and functional parameters of the device are described elsewhere.

Furthermore, an energy source in the form of an accumulator 316 may optionally be connected to the implanted energy transforming device 302 via the control unit 315 to accumulate the received energy for later use by the constriction/stimulation unit 301. Alternatively or additionally, the characteristics of said accumulator, which also reflect the amount of energy required, may be measured as well. The accumulator may be replaced by a rechargeable battery, and the measured characteristics are related to the current state of the battery, or in particular to the temperature of the battery or any electrical parameter such as the power consumption voltage, etc. In order to provide sufficient voltage and current to the constriction/stimulation unit 301, and also to avoid excessive heating, it is clearly understood that the accumulator must be optimally charged by receiving a correct amount of energy from the implanted energy transforming device 302, i.e. neither too little nor too much. The accumulator may also be a capacitor with corresponding characteristics.

For example, the battery characteristics may be measured regularly to determine the current state of the battery, which may then be stored as status information on a suitable storage medium in the internal control unit 315. Thus, each time new measurements are made, the stored battery status information may be updated accordingly. In this way, the battery status may be "calibrated" by transferring a correct amount of energy, so as to maintain the battery in an optimal state.

Thus, the internal control unit 315 of the determining device is adapted to determine the energy balance and/or the amount of energy currently required, (whether energy per unit time or accumulated energy) based on measurements made by the aforementioned sensors or measuring devices of the apparatus, or of the patient, or an implanted energy source if used, or any combination thereof. The internal control unit 315 is further connected to an internal signal transmitter 327 arranged to transmit a control signal reflecting the determined amount of energy required, to an external signal receiver 304c connected to the external control unit 304b. The amount of energy transmitted from the external energy source 304a can then be regulated in response to the received control signal.

Alternatively, the determining device may include the external control unit 304b. In this alternative, the sensor measurements may be transmitted directly to the external control unit 304b where the energy balance and/or the amount of energy currently required may be determined by the external control unit 304b, thereby integrating the above-described function of the internal control unit 315 into the external control unit 304b. In that case, the internal control unit 315 may be omitted and the sensor measurements are supplied directly to the internal signal transmitter 327, which sends the measurements to the external signal receiver 304c and to the external control unit 304b. The external control unit 304b may then determine the energy balance and the amount of energy currently required based on the sensor measurements.

Therefore, the present solution according to the arrangement of FIG. 42 employs feedback of information indicating the required energy, which is more efficient than previous solutions because it is based on actual energy usage which is compared to received energy, for example, with respect to the amount of energy, the difference in energy, or the rate of energy reception compared to the rate of energy used by the implanted energy consuming components of the apparatus. The apparatus may use the received energy both to consume it and to store it in an implanted energy source or the like. The different parameters mentioned above would therefore be used if they are relevant and necessary and, in that case, as a tool to determine the actual energy balance. However, such parameters may also be necessary per se for any action taken internally to specifically operate the apparatus.

The internal signal transmitter 327 and the external signal receiver 304c may be implemented as separate units using suitable signal transfer means, such as radio, IR (infrared), or ultrasonic signals. Alternatively, the internal signal transmitter 327 and the external signal receiver 304c may be integrated into the implanted power transformer device 302 and the external power source 304a, respectively, to transmit the control signals in the reverse direction of power transfer, using substantially the same transmission technique. The control signals may be frequency, phase, or amplitude modulated.

Thus, the feedback information may be transferred by a separate communication system including receivers and transmitters or may be integrated into the power system. In accordance with the present invention, said integrated information and power feedback system comprises an implantable internal power receiver for receiving wireless power, the power receiver having a first internal coil and a first electronic circuit connected to the first coil, and an external power transmitter for transmitting wireless power, the power transmitter having a second external coil and a second electronic circuit connected to the second coil. The second external coil of the power transmitter transmits wireless power that is received by the first coil of the power receiver. This system further comprises a power switch for connecting and disconnecting the connection of the first internal coil to the first electronic circuit, such that the external power transmitter receives feedback information related to the load of the first coil in the form of an impedance variation in the load of the second external coil, when the power switch connects and disconnects the connection of the first internal coil to the first electronic circuit. In implementing this system in the arrangement of Fig. 17, the switch 326 is either separate and controlled by the internal control unit 315, or integrated into the internal control unit 315. It should be understood that the switch 326 should be interpreted in its broadest embodiment. This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or any other electronic component or circuit that can turn power on and off.

To conclude, the power supply arrangement illustrated in FIG. 42 may basically operate as follows. First, the internal control unit 315 of the determining device determines the power balance. A control signal reflecting the amount of power required is also created by the internal control unit 315, and the control signal is transmitted from the internal signal transmitter 327 to the external signal receiver 304c. Alternatively, the power balance may be determined by the external control unit 304b instead, depending on the implementation, as mentioned above. In that case, the control signal may carry measurement results from various sensors. The amount of power output by the external power source 304a may then be regulated by the external control unit 304b, based on the determined power balance, for example, in response to the received control signal. This process may be repeated intermittently at certain intervals during the ongoing energy transfer, or it may run more or less continuously during the energy transfer.

The amount of energy transferred can generally be regulated by adjusting various transmission parameters in the external power source 304a, such as voltage, current, amplitude, wave frequency and pulse characteristics. This system can also be used to obtain information about the coupling factors between the coils of a TET system, even to calibrate the system, both to find an optimal location for the external coil relative to the internal coil and to optimize energy transfer. Simply by comparing in this case the amount of energy transferred with the amount of energy received. For example, if the external coil is moved, the coupling factor can vary and correctly indicated movements could cause the external coil to find the optimal location for energy transfer. Preferably, the external coil is adapted to calibrate the amount of energy transferred to get feedback to the determining device, before the coupling factor is maximized.

This coupling factor information may also be used as feedback during power transfer. In such a case, the power system of the present invention comprises an implantable internal power receiver for receiving wireless power, the power receiver having a first internal coil and a first electronic circuit connected to the first coil, and an external power transmitter for transmitting wireless power, the power transmitter having a second external coil and a second electronic circuit connected to the second coil. The second external coil of the power transmitter transmits wireless power that is received by the first coil of the power receiver. This system further comprises a feedback device for communicating the amount of power received at the first coil as feedback information, and wherein the second electronic circuit includes a determining device for receiving the feedback information and for comparing the amount of power transferred by the second coil with the feedback information related to the amount of power received at the first coil to obtain the coupling factor between the first and second coils. The power transmitter may regulate the transmitted power in response to the obtained coupling factor.

Referring to FIGURE 43, although wireless transfer of power to operate the apparatus has been described above to allow for non-invasive operation, it will be appreciated that the apparatus may be operated with wire-tied power as well. Such an example is shown in FIGURE 43, wherein an external switch 326 is interconnected between the external power source 304a and an operating device, such as an electric motor 307 that operates the constriction/stimulation unit 301. An external control unit 304b controls operation of the external switch 326 to effectuate appropriate operation of the constriction/stimulation unit 301.

44 illustrates different embodiments of how received power may be delivered to and utilized by constriction/stimulation unit 301. Similar to the example in FIG. 56, an internal power receiver 302 receives wireless power E from an external power source 304a that is controlled by a transmission control unit 304b. Internal power receiver 302 may comprise a constant voltage circuit, indicated as a dashed box "constant V" in FIG. 58, for delivering power at a constant voltage to constriction/stimulation unit 301. Internal power receiver 302 may further comprise a constant current circuit, indicated as a dashed box "constant C" in the figure, for delivering power at a constant current to constriction/stimulation unit 301.

The constriction/stimulation unit 301 comprises a power consuming part 301a, which may be a motor, a pump, a restriction device or any other medical device that requires power for its electrical operation. The constriction/stimulation unit 301 may further comprise an energy storage device 301b for storing the energy supplied from the internal energy receiver 302. Thus, the supplied energy may be consumed directly by the power consuming part 301a, or stored by the energy storage device 301b, or the supplied energy may be partially consumed and partially stored. The constriction/stimulation unit 301 may further comprise an energy stabilizing unit 301c for stabilizing the energy supplied from the internal energy receiver 302. Thus, the energy may be supplied in a fluctuating manner, so that it may be necessary to stabilize the energy before it is consumed or stored.

The energy delivered by the internal energy receiver 302 may be stored and/or stabilized by a separate energy stabilizing unit 328, located outside of the constriction/stimulation unit 301, before being consumed and/or stored by the constriction/stimulation unit 301. Alternatively, the energy stabilizing unit 328 may be integrated into the internal energy receiver 302. In either case, the energy stabilizing unit 328 may comprise a constant voltage circuit and/or a constant current circuit.

It should be noted that FIGURE 56 and FIGURE 58 illustrate some possible but non-limiting implementation options with respect to the manner in which the various components and functional elements shown may be arranged and connected to each other. However, the skilled artisan will readily appreciate that many variations and modifications may be made within the scope of the present invention.

FIGURE 45 schematically shows a power balance measurement circuit for one of the proposed designs of the apparatus for monitoring wireless power transmission, or power balance. The circuit has an output signal centered at 2.5V and proportionally related to the power imbalance. The derivative of this signal shows whether the value is going up and down and how fast this change is occurring. If the amount of power received is less than the power used by the implanted components of the apparatus, more power is transferred and thus charged to the power source. The output signal of the circuit is typically passed through an A/D converter and converted to a digital form. The digital information can then be sent to the external power transmission device, allowing it to adjust the level of the transmitted power. Alternatively, a completely analog system can be had using comparators that compare the power balance level to certain maximum and minimum thresholds, sending information to the external power transmission device if the balance goes outside the maximum/minimum window.

The schematic in FIGURE 45 shows an implementation of a circuit for a system that transfers power to the implanted energy components of the apparatus of the present invention from outside the patient's body using inductive power transfer. An inductive power transfer system typically utilizes an external transmitter coil and an internal receiver coil. The receiver coil, L1, is included in the schematic in FIGURE 59; the transmitter portions of the system are excluded.

The implementation of the general concept of energy balance and the way of transmitting information to the external energy transmitter can, of course, be implemented in numerous different ways. The scheme in FIGURE 20 and the method of evaluation and transmission of information described above should only be considered as examples of how to implement the control system.

CIRCUIT DETAILS

In FIGURE 45 the symbols Y1, Y2, Y3, etc., symbolize test points within the circuit. The components in the diagram and their respective values are values that work in this particular implementation, which, of course, is only one of an infinite number of possible design solutions.

The energy to power the circuit is received by the energy receiving coil L1. The energy for the implanted components is transmitted in this particular case at a frequency of 25 kHz. The output signal of the energy balance is present at the test point Y1.

The embodiments described in connection with FIGS. 42, 44, and 45 identify a general method for controlling wireless power transmission to implanted power consuming components of the apparatus of the present invention. Such a method will be defined in general terms below.

Therefore, a method is provided for controlling the transmission of wireless energy supplied to implanted power consuming components of an apparatus as described above. Wireless energy E is transmitted from an external power source located outside of the patient and is received by an internal power receiver located within the patient, the internal power receiver being connected to the implanted power consuming components of the apparatus to directly or indirectly supply the received energy thereto. An energy balance is determined between the energy received by the internal power receiver and the energy used to operate the implanted portions of the apparatus. The transmission of wireless energy E from the external power source is then controlled based on the determined energy balance.

Wireless energy may be inductively transmitted from a primary coil in the external power source to a secondary coil in the internal power receiver. A change in the energy balance may be detected to control wireless energy transmission based on the detected energy balance change. A difference between the energy received by the internal power receiver and the energy used to operate the implanted parts of the apparatus may also be detected to control wireless energy transmission based on the detected energy difference.

By controlling power transmission, the amount of wireless power transmitted can be decreased if the detected change in the energy balance implies that the energy balance is increasing, or vice versa. The decrease/increase in power transmission can further correspond to a detected rate of change.

The amount of wireless power transmitted may be further decreased if the detected power difference implies that the received power is greater than the used power, or vice versa. The decrease/increase in transmitted power may then correspond to the magnitude of the detected power difference.

As mentioned above, the energy used for the operation of the implanted parts of the apparatus is consumed to operate the implanted parts of the apparatus and/or is stored in at least one implanted energy storage device of the apparatus.

When the electrical and/or physical parameters of the implanted parts of the device and/or the physical parameters of the patient are determined, energy can be transmitted for consumption and storage at a transmission rate per unit time that is determined based on said parameters. The total amount of energy transmitted can also be determined based on said parameters.

When a difference is detected between the total amount of energy received by the internal energy receiver and the total amount of energy consumed and/or stored, and the detected difference is related to the time integral of at least one measured electrical parameter related to said energy balance, the integral may be determined for a monitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electrical parameter related to the amount of energy consumed and/or stored, the derivative may be determined for a monitored voltage and/or current related to the energy balance.

The transmission of wireless power from the external power source may be controlled by applying to the external power source electrical pulses from a first electrical circuit for transmitting the wireless power, the electrical pulses having leading and trailing edges, the lengths of first time intervals between successive leading and trailing edges of the electrical pulses varying and/or the lengths of second time intervals between successive leading and trailing edges of the electrical pulses varying, and transmitting wireless power, the transmitted power generated by the electrical pulses having a varied power, the variation in power depending on the lengths of the first and/or second time intervals.

In that case, the frequency of the electrical pulses may be substantially constant by varying the first and/or second time intervals. When the electrical pulses are applied, they may remain unchanged except by varying the first and/or second time intervals. The amplitude of the electrical pulses may be substantially constant by varying the first and/or second time intervals. Furthermore, the electrical pulses may be varied only by varying the lengths of the first time intervals between successive leading and trailing edges of the electrical pulses.

A train of two or more electrical pulses may be supplied in a row, wherein by applying the pulse train, the train having a first electrical pulse at the beginning of the pulse train and having a second electrical pulse at the end of the pulse train, two or more pulse trains may be supplied in a row, wherein the lengths of the second time intervals between the successive trailing edge of the second electrical pulse in a first pulse train and the trailing edge of the first electrical pulse of a second pulse train are varied.

When electrical pulses are applied, they may have a substantially constant current and voltage. The electrical pulses may also have a substantially constant current and a substantially constant voltage. In addition, the electrical pulses may also have a substantially constant frequency. The electrical pulses within a pulse train may also have a substantially constant frequency.

The circuit formed by the first electrical circuit and the external power source may have a first characteristic time period or a first time constant, and by effectively varying the transmitted power, said frequency time period may be in the range of the first characteristic time period or the time constant or be shorter.

The embodiments described in connection with FIGS. 56, 58, and 59 also identify general features for controlling the transmission of wireless power to the implanted power consuming components of the apparatus of the present invention. Such features of the apparatus will be defined in general terms below.

In its broadest sense, the apparatus comprises a control device for controlling the transmission of wireless power from a power transmitting device, and an implantable internal power receiver for receiving the transmitted wireless power, the internal power receiver being connected to the implantable power consuming components of the apparatus to directly or indirectly supply them with the received power. The apparatus further comprises a determining device adapted to determine an energy balance between the energy received by the internal power receiver and the energy used by the implantable power consuming components of the apparatus, wherein the control device controls the transmission of wireless power from the external power transmitting device based on the energy balance determined by the determining device.

Furthermore, the apparatus of the invention may comprise any of the following features:

- A primary coil in the external power source adapted to transmit the wireless power inductively to a secondary coil in the internal power receiver.

- The determining device is adapted to detect a change in the energy balance, and the control device controls the wireless power transmission based on the detected energy balance change.

- The determining device is adapted to detect a difference between the power received by the internal power receiver and the power used for the implantable power consuming components of the apparatus, and the control device controls the wireless power transmission based on the detected power difference.

- The control device controls the external power transmission device to decrease the amount of wireless power transmitted if the detected change in power balance implies that the power balance is increasing, or vice versa, where the decrease/increase in power transmission corresponds to a detected rate of change.

- The control device controls the external power transmission device to decrease the amount of wireless power transmitted if the detected power difference implies that the received power is greater than the used power, or vice versa, where the decrease/increase in power transmission corresponds to the magnitude of said detected power difference.

- The energy used for the implanted parts of the apparatus is consumed to operate the implanted parts, and/or is stored in at least one energy storage device of the apparatus.

- When the electrical and/or physical parameters of the device and/or the physical parameters of the patient are determined, the energy transmission device transmits the energy for consumption and storage according to a transmission rate per unit of time that is determined by the determining device based on said parameters. The determining device also determines the total amount of energy transmitted based on said parameters.

- When a difference is detected between the total amount of energy received by the internal energy receiver and the total amount of energy consumed and/or stored, and the detected difference is related to the time integral of at least one measured electrical parameter related to the energy balance, the determining device determines the integral for a monitored voltage and/or current related to the energy balance.

- When determining the time derivative of a measured electrical parameter related to the amount of energy consumed and/or stored, the determining device determines the derivative for a monitored voltage and/or current related to the energy balance.

- The power transmitting device comprises a coil positioned externally to the human body, and an electrical circuit is provided for supplying the external coil with electrical pulses for transmitting the wireless power. The electrical pulses have leading and trailing edges, and the electrical circuit is adapted to vary first time intervals between successive leading and trailing edges and/or second time intervals between successive leading and trailing edges of the electrical pulses to vary the power of the transmitted wireless power. As a result, the power receiver receiving the transmitted wireless power has a varied power.

- The electrical circuit is adapted to supply the electrical pulses so that they remain unchanged except by varying the first and/or second time intervals.

- The electrical circuit has a time constant and is adapted to vary the first and second time intervals only in the range of the first time constant, so that when the lengths of the first and/or second time intervals are varied, the power transmitted to the coil is varied.

- The electrical circuit is adapted to supply the electrical pulses to vary only by varying the lengths of the first time intervals between successive leading and trailing edges of the electrical pulses.

- The electrical circuit is adapted to supply a train of two or more electrical pulses in a row, said train having a first electrical pulse at the beginning of the pulse train and having a second electrical pulse at the end of the pulse train, and

- the lengths of the second time intervals between the successive trailing edge of the second electrical pulse of a first pulse train and the leading edge of the first electrical pulse of a second pulse train are varied by the first electronic circuit.

- The electrical circuit is adapted to provide the electrical pulses as pulses having a substantially constant height and/or amplitude and/or intensity and/or voltage and/or current and/or frequency.

- The electrical circuit has a time constant, and is adapted to vary the first and second time intervals only in the range of the first time constant, so that when the lengths of the first and/or second time intervals are varied, the power transmitted over the first coil is varied.

- The electrical circuit is adapted to provide the electrical pulses by varying the lengths of the first and/or second time intervals only within a range that includes the first time constant or that is relatively close to the first time constant, compared to the magnitude of the first time constant.

While the invention has been described in relation to what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but is instead intended to cover various modifications and equivalent arrangements included within the scope of the appended claims.

Claims (9)

1. An apparatus for controlling the flow of urine in the urethra of a patient, comprising: an implantable adjustable constriction device (2) for constricting the urethra to influence flow in the urinary tract; a control device (315) for controlling the constriction device, wherein the control device is configured to control the constriction device to constrict the urethra or release a constriction of the urethra; and an operating device for operating the constriction device to change the constriction of the urethra; and a battery (302) for supplying power to the operating device; characterized in that the control device comprises a temperature sensor configured to detect a temperature related to excessive heating caused by the battery. 2. The apparatus according to claim 1, wherein the temperature sensor is configured to detect the temperature of the battery. 3. The apparatus according to claim 1, wherein the control device further comprises an internal signal transmitter (327) arranged to transmit a signal based on the temperature measurement. 4. The apparatus according to claim 3, wherein the internal signal transmitter is arranged to transmit the signal to an external signal receiver (304c). 5. The apparatus according to claim 4, wherein the temperature sensor is configured to measure the temperature regularly, and wherein the control device is configured to store the measured values. 6. The apparatus according to claim 5, wherein the control device is connected to the internal signal transmitter, and wherein the internal signal transmitter is configured to transmit the stored measured values to an external signal receiver. 7. The apparatus according to claim 1, wherein the control device is programmable. 8. The apparatus according to claim 1, wherein the operating device is configured to mechanically operate the constriction device. 9. The apparatus according to claim 8, wherein the operating device comprises a motor (115) and a gearbox (127) connected to the motor.